Senior/Principal Manufacturing Asset Engineer, HTO

Full-time - Senior

Hillsboro, OR

Professional, Scientific, and Technical Services

About the position

The Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche's commercial portfolio & pipeline products. The Operations organization at HTO is divided into 2 value streams, which combine to produce millions of units of life-saving medicine every year to patients around the world.

Responsibilities

• Support the design, operation, control and optimization of manufacturing equipment at HTO.
• Serve as the equipment owner and engage in development, qualification, data analysis, troubleshooting, and continuous improvement activities.
• Provide technical support and engineering solutions for process and equipment-related issues.
• Ensure that the equipment/systems remain in their qualified state and in alignment with Good Manufacturing Practices and all relevant Roche standards.
• Collaborate with leadership to establish priorities, targets and milestones.
• Represent the department functionally, cross-functionally and cross-site for various activities and initiatives.
• Provide on-floor support to the Manufacturing teams regarding equipment.
• Ensure issues are identified and captured in the relevant quality management system, and that proper root cause analysis is performed with appropriate corrective and preventative actions assigned.
• Contribute to the development of maintenance strategies, asset monitoring strategies, asset life-cycle management strategies, qualification strategies, spare part stocking strategies, etc.
• Ensure changes, maintenance and other interventions do not impact the qualified state of the equipment and provide maintenance oversight for process equipment.
• Use data-driven analysis of process and equipment to understand performance and capacity.
• Identify, recommend, and implement improvements to optimize system performance.
• Ensure process operations comply with all health, safety, and environmental policies and procedures.

Requirements

• B.S or higher in Mechanical Engineering, Electrical, Chemical, Biochemical, or related discipline.
• 8-11 years experience in the pharmaceutical or biotechnology industry for a Senior Engineer and 12+ for a Principal Engineer level.
• Self-motivated team player with the ability to work, prioritize, and deliver results with minimal supervision.
• Demonstrated success operating in teams, especially cross-functional teams.
• Strong organizational, computer, and analytical skills.
• Experience in capital project design, development, and execution.
• Understanding of drug product and/or finished goods processes & equipment.
• Experience in commissioning, qualification and validation activities associated with aseptic processes, technology transfers and new product commercialization.

Benefits

• Discretionary annual bonus based on individual and Company performance.
• Relocation benefits available.